Events

Recall of PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01623-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01623-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The barcode and value sheet for a single lot of precicontrol varia contain an erroneous target value for control level 2, when used with certain lots of elecsys pth assay on cobas e 411 analyser. the deviation between the correct & erroneous value is 20% for pth lot 185000 & 31% for pth lot 143251. this issue can be detected because it will cause elevated level 2 control recoveries. also it can be detected if both control levels 1 & 2 are run prior to measurement of patient samples. if only control level 2 is used and a local issue occurs in the lab where false-low pth results of -20% to -31% are obtained, the control would be within range and consequently false-low results could be reported. in an intra-operative measurement scenario, an erroneous low pth result can result in an incorrect conclusion that tumour resection was complete. in the worst case, remaining cancerous or hyperplastic tissue may be left undetected. to date, no customer complaints have been received by roche.
  • Action
    Roche is providing users with the correct control level 2 target values for the PTH assay on an updated value sheet. The correct target value is to be manually entered by the user, noting there is a reagent lot-specific value for Elecsys PTH lot 143251 and for other lots the PTH value target value should be used as per routine operation. This action has been closed-out on 25/05/2017

Device

PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 anal...
  • Model / Serial
    PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD).PreciControl Varia Material Number: 05618860190Lot Number: 18928501Elecsys PTH assayMaterial Number: 11972103122Lot Number: 185000, 143251ARTG Number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited